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  • Writer's pictureTessa Putri H.

UFI for FDA Facility Registration Purposes - Human & Animal Food

In order to export food and beverages to USA, whether it is for human or animal, every manufacturers and suppliers have to comply with current applicable FDA regulations. One of the requirements for customs clearance process in the USA is the FDA facility registration number, also known as the FFR number, for both the importer and exporter. The FFRN itself is not the FDA certification for the exported products--it is the identification for the processing/storing facility of the mentioned food or beverages product.

Why are food facilities required to register with the FDA?

Food facility registration helps FDA determine the location and source of potential bioterrorism or foodborne illness outbreak incidents, and also helps the agency quickly notify facilities that may be affected.

Domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to register with FDA. Registered facilities are required to renew the registrations. Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] requires food facilities that are required to register with FDA to renew such registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year.

Please be advised that “updating” your registration is a different function than “renewing” your registration. During the renewal period, you will not see the “Update” button listed on the FFRM main menu, until the registration is renewed. If a registration is not renewed by 11:59 PM on December 31 of the even-numbered year, the registration is considered expired and will be removed from your account. FDA will cancel a registration if the facility’s registration has expired because the facility has failed to renew its registration as required. In addition, all facilities must include a unique facility identifier (UFI) recognized as acceptable to FDA with the registration submission. FDA UFI For Food Facility Registrations Beginning October 1, 2020, as per 21 CFR 1.232 (a) (2), domestic and foreign facilities must submit a Unique Facility Identifier (UFI) recognized as acceptable to FDA in their food facility registrations. To date, FDA recognizes the Data Universal Numbering System D-U-N-S (DUNS) number as an acceptable UFI. The DUNS number is assigned and managed by Dun & Bradstreet. We understand that complying a country's regulation in order to be able to export our product there is indeed a meticulous process. Hence, should you need more details on the process on getting the UFI and the FDA Food Registration, you can always reach us through email or WhatsApp. We provide free consultancy for all members, assisted by our FDA specialist.

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